Institutional Biosafety Committee

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Institutional Biosafety Committee à la BASF
Plant Science L.L.C. NIH The Future Face of
Institutional Biosafety Committees Oswaldo da
Costa e Silva, Ph.D. IBC Chairman February 21,
2003
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BASF Plant Science A World Research Platform
External cooperations
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History of the BASF Plant Science L.L.C. IBC

• Decision to work under the NIH guidelines for
  rDNA work
• Registration of the IBC at the NIH (January 11,
  2000)
• Decisions of the first IBC meeting (May 4, 200)
• Approval of the BASF Plant Science L.L.C.
  Biosafety Manual
• Approval of the Acknowledgment Form
• Approval of the Project Submission Form
• Approval of the Project Approval Procedure

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Members of the BASF Plant Science LLC IBC
Bryan McKersie, Ph.D. (Deputy Chairman) Head of
Enabling Technologies and Trait Development, BASF
Plant Science LLC Special Area Genetically
modified plants, release experiments with
transgenic plants   Charles Spacek Facility
Manager, BASF Corp, Research Triangle
Park Special Area Facility safety issues,
facility structural safety issues   Oswaldo da
Costa e Silva, Ph.D. (Chairman) Head of Gene
Discover, BASF Plant Science LLC Special Area
Recombinant DNA research, genetically modified
microorganisms, plant pathogens   Heiko Haertel,
Ph.D. Research Scientist, BASF Plant Science
LLC Special Area Biochemistry and physiology of
transgenic plants   Rui-Guang Zhen,
Ph.D. Research Scientist, BASF Plant Science
LLC Special Area Recombinant DNA research,
analysis of gene expression   Steven Spiker,
Ph.D. Professor of Genetics, North Carolina State
University Special Area Recombinant DNA
research, genetically modified plants, community
aspects   William Thompson, Ph.D. Professor of
Botany, North Carolina State University Special
Area Genetically modified plants, recombinant
DNA research, community aspects
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Areas of Expertise in the BASF Plant Science IBC
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Biosafety Manual

• Highest level of regulations (sometimes more
  stringent as the NIH Guidelines)
• Version 4 June 2002
• Regulates work with
• rDNA Plasmids and Phages
• Microbial GMOs E.coli and budding yeast
• Plant GMOs Arabidopsis, Corn, Soybean, Wheat,
  Alfalfa, Ryegrass
• Regulates work in
• Laboratory
• Greenhouse
• Growth-Chamber
• Field

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Acknowledgement Form

• Background
• The IBC delegates the responsibility for
  understanding, compliance and training to the PIs

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Project Approval Form

• PI is responsible to give all required
  information to the IBC
• The IBC is especially interested in Risk
  Assessment issues
• Operator, and
• Environment, transgenic plants

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Project Approval Procedure Hot Mail
Submission of Project Proposal Form (Principal
Investigator)
(Has never happened)
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How busy have we been?
We have dealt so far only with BL1 and BLP1
proposals. The laboratories are equipped for BL2
work
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Hot Mail A Successful Way to Communicate and
Save Time

• We have used the Hot Mail procedure for
• Project Proposal Approval
• Changes in the Biosafety Manual
• Changes in the Greenhouse Practices with
  Transgenic Plants
• Advantages
• Speedy Response
• Flexible Schedule
• Disadvantages
• Extra Coordination needed
• Few / no face-to-face meetings

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Other Functions of the IBC
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Training of the Scientists on rDNA / GMO Work

• The IBC is responsible for assuring the correct
  training of all BASF Plant Science L.L.C.
  employees in rDNA and GMO work
• Yearly Refresher Seminar for the whole group
• Project Approval Procedure
• Basic work procedures
• New Principal Investigators

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Coordination of the Work with Transgenic Plants

• Transgenic Plant Log File
• Excel dB in shared drive
• Allows immediate monitoring of transgenic plants
  in Greenhouse
• Records
• Unique Identifier
• Principal Investigator
• Contact Scientist
• Plant Species
• Vector (Vector dB)
• Planting Date
• Disposal Date

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Defining and Implementing Internal Procedures

• Work with BASF Plant Science Biosafety
  Regulatory Group
• Objectives of this Group
• Common, as common as possible, rDNA/GMO
  Regulations among sites
• Interactions, Exchange of material across sites
• Coordination of worldwide Field Trials
• Uniform Contact to Regulatory Agencies

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Contact with Regulatory Authorities

• The BASF Plant Science L.L.C. IBC has been the
  contact point to US regulatory agencies
• NIH Support and assistance in the
  establishment of the IBC
• USDA Field trials and structural changes in
  the greenhouses
• North Carolina Dept. of Agriculture Structural
  changes in the greenhouses
• It has been a very productive and fruitful
  interaction

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Thank You!